FDA EIR - Anil Kumar, M.D. - November 02, 2011

An FDA Bioresearch Monitoring inspection of Anil Kumar, M.D., specializing in Cardiology, was conducted from October 11 to November 2, 2011, in Lancaster, CA. This initial inspection, requested by the Office of Scientific Investigations under the regulatory framework for clinical investigators, focused on three clinical trial studies. The primary violations identified included a failure to maintain accurate and complete case histories, as well as significant deviations from the investigational plan. Specifically, for one study protocol, it was discovered that a former study coordinator had falsified laboratory safety reports for 11 subjects by duplicating previous test results and altering dates. This was done to conceal the fact that required Visit 3 laboratory tests had not been performed, constituting a major protocol deviation. Dr. Kumar acknowledged his responsibility for monitoring staff activities and promptly reported the data fabrication to the sponsor and the Institutional Review Board upon discovery. The previous coordinator was subsequently terminated for unrelated reasons. Additional minor issues noted included incomplete authorization signatures on informed consent documents for certain subjects in another study, which were later corrected. Dr. Kumar received an FDA Form 483 detailing these inspectional observations and committed to submitting a written response to the FDA within 15 business days, outlining his proposed corrective actions.